BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT ALUMINA INSERT

    MDR report key: 3233550 · Received July 18, 2013

    Report

    Report Number
    0002249697-2013-02360
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 21, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MRA
    PMA / PMN Number
    P000013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING WEAR/PAIN INVOLVING A TRIDENT LINER WAS REPORTED. THE EVENT WAS NOT CONFIRMED. THE DEVICE WAS NOT RETURNED DUE TO HOSPITAL POLICY. A REVIEW OF THE PROVIDED INFORMATION BY A CLINICAL CONSULTANT COULD NOT DETERMINE THE ROOT CAUSE AS READABLE X-RAYS, CLINICAL HISTORY AND OPERATIVE REPORTS ARE NEEDED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION, INCLUDING OPERATIVE REPORTS, PROGRESS NOTES, AND X-RAYS ARE NEEDED TO FULLY INVESTIGATE THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT COMPLAINED OF CHRONIC HIP PAIN, SURGERY WAS PERFORMED TO EXPLANT OLD IMPLANTS, AND AN MDM WAS IMPLANTED. PATIENT DID NOT PROVIDE SPECIFICS LAST SURGERY DATE. THE OLD IMPLANTS WERE UNABLE TO BE IDENTIFIED BY SPECIFIC LOT#. ON (B)(6) 2013, ADDITIONAL INFORMATION INDICATED THAT THE PATIENT HAD PAIN A FEW YEARS AFTER THE INITIAL SURGERY. AN X-RAY CONFIRMED SWELLING OF THE SOFT TISSUE AND UPON REVISION, THE SURGEON NOTED WEAR. IN ADDITION TO THE ACETABULAR COMPONENTS THAT WERE REVISED, THE STEM, (B)(4) WAS ALSO REMOVED. IT WAS ALSO NOTED THAT THE PATIENT'S PAIN WAS ORIGINATING FROM THE STEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT COMPLAINED OF CHRONIC HIP PAIN, SURGERY WAS PERFORMED TO EXPLANT OLD IMPLANTS, AND AN MDM WAS IMPLANTED. PATIENT DID NOT PROVIDE SPECIFICS LAST SURGERY DATE. THE OLD IMPLANTS WERE UNABLE TO BE IDENTIFIED BY SPECIFIC LOT#. ON JULY 2, 2013, ADDITIONAL INFORMATION INDICATED THAT THE PATIENT HAD PAIN A FEW YEARS AFTER THE INITIAL SURGERY. AN X-RAY CONFIRMED SWELLING OF THE SOFT TISSUE AND UPON REVISION, THE SURGEON NOTED WEAR. IN ADDITION TO THE ACETABULAR COMPONENTS THAT WERE REVISED, THE STEM, 6054-0812S WAS ALSO REMOVED. IT WAS ALSO NOTED THAT THE PATIENT'S PAIN WAS ORIGINATING FROM THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334081 TRIDENT ALUMINA INSERT IMPLANT MRA STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization| R